Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses
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| ClinicalTrials.gov Identifier: NCT01155323 |
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Recruitment Status :
Completed
First Posted : July 1, 2010
Results First Posted : October 4, 2011
Last Update Posted : June 19, 2018
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Sponsor:
Johnson & Johnson Vision Care, Inc.
Collaborators:
Johnson & Johnson K.K. Medical Company
Visioncare Research Ltd.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment |
| Condition |
Myopia |
| Interventions |
Device: etafilcon A Device: omafilcon A |
| Enrollment | 118 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Etafilcon A/Omafilcon A | Omafilcon A/Etafilcon A |
|---|---|---|
 Arm/Group Description |
etafilcon A contact lenses will be worn first and omafilcon A contact lenses will be worn second. | omafilcon A contact lenses will be worn first and etafilcon A contact lenses will be worn second. |
| Period Title: First Intervention | ||
| Started | 60 | 58 |
| Completed | 59 | 57 |
| Not Completed | 1 | 1 |
| Reason Not Completed | ||
| exclusion criteria | 1 | 1 |
| Period Title: Second Intervention | ||
| Started | 59 | 57 |
| Completed | 58 | 56 |
| Not Completed | 1 | 1 |
| Reason Not Completed | ||
| Lost to Follow-up | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Total Number of Participants | |
|---|---|---|
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Arm/Group Description |
This represents all subjects that completed the study minus one additional subject excluded due the discovery after study completion that the subject conflicted with exclusion criteria. | |
| Overall Number of Baseline Participants | 113 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 113 participants | |
| 25.3 (4.4) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 113 participants | |
| Female |
80 70.8%
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| Male |
33 29.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| Singapore | Number Analyzed | 113 participants |
| 113 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The results of the study may not be published or publicly presented without prior written approval of the sponsor. If the investigator wishes to publish or present any study findings, investigator shall contact sponsor to discuss publication plan.
Results Point of Contact
| Name/Title: | Wakana Katabami |
| Organization: | Johnson and Johnson K.K. |
| Phone: | 81-34411-8040 ext 22025 |
| EMail: | wkatabam@its.jnj.com |
| Responsible Party: | Johnson & Johnson Vision Care, Inc. |
| ClinicalTrials.gov Identifier: | NCT01155323 |
| Other Study ID Numbers: |
CR-0926 DISP-523 ( Other Identifier: Visioncare Research Ltd ) |
| First Submitted: | June 30, 2010 |
| First Posted: | July 1, 2010 |
| Results First Submitted: | August 29, 2011 |
| Results First Posted: | October 4, 2011 |
| Last Update Posted: | June 19, 2018 |